Apparatus and processes for applying substances within mammalian tissue

ABSTRACT

An apparatus for applying a substance to internal mammalian tissue is provided. The apparatus includes a member having a flexible, absorbent, porous portion connected to a non-porous portion. The apparatus may be used to treat atrial fibrillation or other non-atrial fibrillation issues with internal mammalian tissue.

FIELD OF THE DISCLOSURE

The disclosure relates to apparatus and processes for applyingsubstances within mammalian tissue to chemically treat atrialfibrillation, or to chemically treat other types of non-atrialfibrillation issues involving internal mammalian tissue.

BACKGROUND OF THE DISCLOSURE

Atrial fibrillation is one of the most common arrhythmias in the worldand is recognized as one of the most serious medical epidemics. Atrialfibrillation is a leading cause of stroke, thromboembolism, mortality,and debilitation. Common debilitating symptoms of atrial fibrillationinclude but are not limited to palpitations, dyspnea, dizziness, chestpain, weakness, and long term debility associated with stroke andcongestive heart failure. There is a large economic burden to societyassociated with atrial fibrillation including: medical care costsresulting from medical therapy, symptom relief, hospitalizations, andinvasive procedure and device therapy; lost time from the workforce; andlong term care costs associated with morbidity of stroke, heart failure,and debilitation.

The current drug-related therapies for atrial fibrillation requirerelatively high doses of drugs systemically to effect the substratetissue in the atrium in order to have any positive effect. However,these drugs have serious side effects, and are largely inadequate. Onetherapy for atrial fibrillation comprises ventricular rate controldrugs. However, common side effects of this therapy include bradycardia,weakness, low energy levels, and other side effects. Moreover, thistreatment may require pacemaker implantation which is invasive andcostly. Another adjunctive therapy for atrial fibrillation comprisesblood thinners. However, blood thinners have significant side effectsand may lead to minor and catastrophic bleeding complications, mayrequire frequent blood tests, and may have a narrow and difficult toachieve therapeutic window to achieve therapeutic blood levels. Stillanother therapy for atrial fibrillation comprises antiarrhtyhmic drugs.However, antiarrhtyhmic drugs have a limited effectiveness inmaintaining normal heart rhythm, and have a wide range of toxic systemicside effects. Moreover, antiarrhtyhmic drugs may induce pro-arrhythmia,and have negative drug interactions with other medications.

The current procedural therapies for atrial fibrillation are alsolargely inadequate. One procedure for atrial fibrillation compriseselectrical cardioversion. This procedure requires sedation or generalanesthesia. Moreover, atrial fibrillation commonly reoccurs afterelectrical cardioversion. Another procedure for atrial fibrillationcomprises invasive catheter ablation such as: radiofrequency ablation;cryothermy; ultrasound ablation; laser ablation; or electrical ablation.Catheter ablation is intended to ablate arrhythmogenic cells in oraround the left atrium. The majority of cases are known to originatefrom the endocardium or myocardium within or around the pulmonary veins.Creating circumferential ablation lesions around pulmonary veins isintended to cause electrical isolation of the abnormal cells within thepulmonary veins, rending these trigger zones unable to propagateabnormal electrical impulses into the left atrium, making them incapableof causing atrial fibrillation. Pulmonary vein ablation for atrialfibrillation remains a promising therapy, but has proven to be each ofthe following: limited in efficacy; have risks and complicationsassociated with an invasive procedure; require specialized skill andtraining leading to higher costs, and a lower number of patients thatcan be treated due to the lack of operators with this specializedtraining; require a long procedure time to effectively map, throughelectrophysiology mapping, specific trigger zones around the pulmonaryvein ostia prior to delivering the catheter based injury; and oftenrequire repeat procedures for a successful outcome. Moreover, currentcatheter ablation techniques are limited in their success in part due tothe inability to deliver the ablative injury to all substrate tissuethat causes atrial fibrillation. This limitation may leave potentialgaps in the target area of ablation that is not treated. This is oftencaused due to limitations in controlling the catheter tip and theinability to provide multiple burns at the end of the catheter in thesame spot due to the risk of perforation. Frequently, patients arerequired to return for multiple repeat procedures in attempts to ablatemissed areas. Current catheter-based therapies are hampered by theirinability to consistenty, effectively, and predictably createcircumferential, continuous, or curvilinear ablation lines to eradicateorigins of irregular electrical activity, and to isolate the targettissue from further propagating abnormal electrical impulses. Seriouscomplications related to current ablation therapies include: left atrialperforation leading to hemopericardium and cardiac tamponade; pulmonaryvein stenosis; left atrial-espohageal fistula; thromboembolic events,such as stroke and myocardial infarction, resulting directly from injurycreated by current equipment and techniques, and other complications.

An apparatus and process is needed to effectively treat atrialfibrillation, or other types of non-atrial fibrillation issues involvingmammalian tissue, while avoiding one or more of the side-effectsassociated with the current treatments.

SUMMARY OF THE DISCLOSURE

In one embodiment, an apparatus for applying a substance to internalmammalian tissue comprises a member having a flexible, absorbent, porousportion connected to a non-porous portion.

In another embodiment, a balloon-catheter for applying a substance tointernal mammalian tissue comprises: an inflatable and deflate-ableballoon comprising a flexible, absorbent, porous portion connected to anon-porous portion to form a cavity; and a catheter connected to theballoon.

In an additional embodiment, a guide-wire is provided having a portionfor being magnetized, and another portion which is non-magnetic.

In an additional embodiment, a method of applying a substance tointernal mammalian tissue is provided. In one step, a member is deployedwithin a mammal. In another step, a flexible, absorbent, porous portionof the member is disposed against internal tissue of the mammal. In anadditional step, a substance, disposed in a cavity between the flexible,absorbent, porous portion of the member and a non-porous portion of themember, is infused through the flexible, absorbent, porous portion tocontact the internal mammalian tissue.

These and other features, aspects and advantages of the disclosure willbecome better understood with reference to the following drawings,description and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of one embodiment under thedisclosure of an apparatus for applying a substance to internalmammalian tissue;

FIG. 1A illustrates a top view of the apparatus of FIG. 1;

FIG. 2 illustrates one embodiment under the disclosure of a guide-wire;

FIG. 3 illustrates a side view of the apparatus of FIG. 1 being deployedwithin a mammal over the guide-wire of FIG. 2 with the apparatuspartially stowed within a sheath;

FIG. 4 illustrates a perspective view of the apparatus of FIG. 3 beingextended out of the sheath within the mammal;

FIG. 5 illustrates the perspective view of the apparatus of FIG. 4 withthe apparatus having been inflated.

FIG. 6 illustrates the perspective view of the apparatus of FIG. 5 witha substance being infused through the apparatus into mammalian tissue;

FIG. 7 illustrates a perspective view of the apparatus of FIG. 6 withthe apparatus being deflated;

FIG. 8 illustrates a perspective view of the apparatus of FIG. 7 withthe apparatus beginning to be retracted back into the sheath;

FIG. 9 illustrates a perspective view of the apparatus of FIG. 8 withthe apparatus further retracted back into the sheath; and

FIG. 10 illustrates a perspective view of the apparatus of FIG. 9 withthe apparatus completely retracted back into the sheath.

DETAILED DESCRIPTION OF THE DISCLOSURE

The following detailed description is of the best currently contemplatedmodes of carrying out the disclosure. The description is not to be takenin a limiting sense, but is made merely for the purpose of illustratingthe general principles of the disclosure, since the scope of thedisclosure is best defined by the appended claims.

FIGS. 1 and 1A illustrate one embodiment under the disclosure of anapparatus 10 for applying a substance 12 to internal mammalian tissue.For purposes of this disclosure, the term ‘mammal’ comprises ahuman-being or any type of animal. The apparatus 10 includes a member 16having a flexible, absorbent, porous portion 18 connected to anon-porous portion 20. For purposes of this disclosure, the term‘flexible’ means bending readily without breaking. For purposes of thisdisclosure, the term ‘absorbent’ means a material which has the capacityor tendency to absorb a substance. For purposes of this disclosure, theterm ‘non-porous’ means not permeable to water, or other fluids. Themember 16 may comprise a medical device. The flexible, absorbent,porousportion 18 is absorbent, is porous or partially porous, and willsaturate or partially saturate with the substance 12 allowing thesubstance 12 to pass through the flexible, absorbent, porous portion 18.For purposes of this disclosure, the term ‘porous’ means a materialhaving pores which allow fluids to pass through the material. Theflexible, absorbent, porous portion 18 is sufficiently soft, malleable,and compliant, such that when gentle pressure is applied by an operatorto press it against an endocardial surface during an atrial fibrillationtreatment, or other medical treatment, the flexible absorbent portion 18will compress and be in complete opposition to the endocardial surfacefilling the crevices of the endocardial surface regardless of anysurface irregularities in endocardial surface topography. The apparatus10 may be used to apply the substance 12 to any type of internalmammalian tissue. The flexible, absorbent, porous portion 18 may be madeof any flexible, absorbent, saturating material such as foam, syntheticfoam, foam rubber, natural sponge, synthetic sponge, synthetic rubber,or other materials that will absorb the substance 12 and will expandwhen saturated to fully adhere to the surface being treated. Thenon-porous portion 20 may be made of a standard cardiovascularangioplasty balloon material which is non-porous and non-absorbent whichwill not absorb or extrude the substance 12. The member 16 may comprisean inflatable and deflate-able cavity 22 formed between the flexible,absorbent, porous portion 18 and the non-porous portion 20. The member16 may comprise a balloon-catheter comprising an inflatable anddeflate-able balloon 24 connected to a catheter 26. The flexible,porous, absorbent portion 18 may comprise the top-half of the balloon24, and the non-porous portion 20 may comprise the bottom-half of theballoon 24. In other embodiments, the flexible, absorbent, porousportion 18 and the non-porous portion 20 may vary in shape, size,orientation, configuration, or relation to one another. The member 16may include a nipple 28 extending from a top end 30 of the flexible,absorbent, porous portion 18. A tapered hole 29 may extend through thenipple 28. The tapered hole 29 may end at a base surface 31 of thenipple 28. The member 16 may comprise first, second, and third lumens32, 34, and 36. The catheter 26 may comprise first and second catheterlumens 37 and 39. The first lumen 32 may comprise an open-ended,through-lumen which extends continuously from and through the nipple 28in the top end 30 of the flexible, absorbent, porous portion 18, throughthe cavity 22 of the member 16, to and through a bottom end 38 of thenon-porous portion 20. The first lumen 32 may be aligned with the firstcatheter lumen 37 of the catheter 26 to form a continuous through-lumen.The first lumen 32 may extend along and through a long axis 42 of themember 16. The first lumen 32 may have a width 44. In other embodiments,there may be any number of first lumen 32 of varying shape, size,configuration, or orientation. The second lumen 34 may comprise two,spaced-apart, open-ended, through lumens which extend continuously fromand through lateral surfaces 46 of the member 16, through the cavity 22of the member 16, to and through the top end 30 of the member 16. Thesecond lumen 34 may extend from the non-porous portion 20 of the member16 through the nipple 28 of the top end 30 of the flexible, absorbent,porous portion 18 of the member 16. As shown in FIG. 1A, the secondlumen 34 may be crescent-shaped. In other embodiments, there may be anynumber of second lumen 34 of varying shapes, sizes, configurations, ororientations. The third lumen 36 may comprise a closed-end lumenextending from the second catheter lumen 39 into the closed-end,inflatable and deflate-able cavity 22. In other embodiments, there maybe any number of third lumen 36 of varying shape, size, configuration,or orientation. The member 16 may further comprise a ferromagneticportion 48 which may be disposed in the nipple 28, in the base surface31 of the nipple 28, or in any other portion of the member 16. In otherembodiments, the ferromagnetic portion 48 may be disposed in varyingportions of the member 16. The member 16 may optionally include one ormore Nitinol runners 49 that are connected between the flexible,absorbent, porous portion 18 and the catheter 26. In other embodiments,the member 16, including all of its components, may be of a varyingshape, size, configuration, or orientation.

FIG. 2 illustrates one embodiment under the disclosure of a guide-wire50. The guide-wire may 50 have a diameter of 0.025 inches, 0.035 inches,or 0.038 inches. In other embodiments, the size of the guide-wire 50 mayvary. The guide-wire 50 may have a stepped-up portion 52 which has awidth 54 which is greater than widths 56 of other portions 58 of theguide-wire 50. The width 54 of the stepped-up portion 52 may also begreater than a width 44 of the first lumen 32 of the member 16 shown inFIGS. 1 and 1A. The guide-wire 50 may also have a portion 60 having anelectromagnet or any other mechanism or material with magneticcapability for being magnetized by magnetic inducing apparatus known inthe art. The portion 60 may comprise the stepped-up portion 52. In otherembodiments, the portion 60 may be different than the stepped-up portion52. The portion 60 for being magnetized may comprise a ferromagneticcore with a surrounding wire coil, helical arrangement, solenoid,corkscrew arrangement, or other configuration for being magnetized. Whenan electric current is applied to the magnetic portion 60, such as byhooking up ends 61 and 63 of the portion 60 to a device supplyingpositive and negative charges, an electromagnetic field will be createdin order to attract or repulse the ferromagnetic portion 48 of themember 16 relative to the magnetic portion 60. In such manner, themagnetic portion 60 of the guide-wire 50 may be used to control precisemovement of the member 16 when disposed within a pulmonary vein or othertissue of a mammal. The strength of the attraction or repulse may becontrolled by the strength of the electrical current applied. When theelectrical current is turned off, the magnetic field is eliminatedallowing the guide-wire 50 to operate as a standard guide-wire. Theguide-wire 50 may also have another portion 62 which is non-magnetic.Portion 62 may comprise an insulating, non-magnetic material coveringmost of portion 60. In one embodiment, portion 62 may cover the entireportion 60 with the exception of at the ends 61 and 63, and at thestepped-up portion 52. In other embodiments, the portion 62 may covervarying segments of portion 60 in varying shapes, sizes, orientations,or configurations.

FIGS. 3-10 illustrate various steps of a method for the apparatus 10being deployed in a mammal to apply a substance 12 to internal mammaliantissue 64. As illustrated in FIG. 3, the apparatus 10 may be deployedwithin the mammal. The apparatus 10 may comprise a member 16 comprisinga balloon-catheter comprising an inflatable and deflate-able balloon 24connected to the catheter 26. The member 16 may be deployed by insertinga guide-wire 50 from across an interatrial septum into a pulmonary vein76 of the mammal, such as the left superior pulmonary vein, the leftinferior pulmonary vein, the right superior pulmonary vein, or the rightinferior pulmonary vein. A stepped-up portion 52 of the guide-wire 50may be inserted into a hole 75 of the left atrium 74 and extended into apulmonary vein ostium 78 of the pulmonary vein 76. The balloon 24 may bedelivered towards the internal mammalian tissue 64, with the balloon 24partially stowed in an unexpanded/deflated stated within a sheath 68, byfollowing the first lumen 32 of the balloon 24 along the guide-wire 50disposed in the pulmonary vein 76. In order to minimize the risk ofthrombus formation on the member 16, the mammal may be adequatelyanticoagulated with systemic medications including but not limited tounfractionated heparin, warfarin, low-molecular weight heparin,direct-thrombin inhibitor, glycoprotein 2b/3a antagonists, aspirin,clopidogrel, prasugrel, thrombolytic agents, or other types ofanticoagulation medications. During this process, the nipple 28 of theballoon 24 may be disposed outside of the sheath 68, with the remainderof the deflated balloon 24 disposed within the sheath 68. By pushing thesheath 68 or the catheter 26 towards the internal mammalian tissue 64,the nipple 28 of the balloon 24 may be extended into the hole 75 of theleft atrium 74 and extended into the pulmonary vein ostium 78 of thepulmonary vein 76 to come to a resting location disposed apart from thestepped-up portion 52 of the guide-wire 50. The nipple 28 may be sizedto fit snugly against the hole 75 of the left atrium 74 to assist insecuring the balloon 24 in place.

As illustrated in FIG. 4, during deployment the sheath 68 may be pulledaway from the internal mammalian tissue 64 and the catheter 26 may bepushed towards the internal mammalian tissue 64 to move the remainingportion of the deflated balloon 24 outside the sheath 68 towards theinternal mammalian tissue 64. In one embodiment, the internal mammaliantissue 64 to be treated may comprise pulmonary vein ostial tissue,pulmonary vein tissue 76, or an endocardial surface of the left atrium74. During this process, the flexible, absorbent, porous portion 18 ofthe member 16 may pop-out of the sheath 68 and extend into its naturaluncompressed state disposed against the internal mammalian tissue 64.The non-porous portion 24 of the member 16 may begin to un-crinkle asthe flexible, absorbent, porous portion 18 extends. The flexible,absorbent, porous portion 18 may have a shape that will juxtapose,adhere, or make contact with the internal mammalian tissue 64, which maycomprise pulmonary vein ostial tissue, pulmonary vein tissue 76, or theendocardial surface, of the left atrium 74. This shape may be circular,ovoid, elliptical or another shape. In one embodiment, the process maycomprise an operator pushing the catheter 26 until the flexible,absorbent, porous portion 18 of the balloon 24 is disposed against theinternal mammalian tissue 64, which may comprise the pulmonary veinostial tissue, pulmonary vein tissue 76, or the endocardial surface, ofthe left atrium 74. In another embodiment, the process may compriseattracting and moving a ferromagnetic portion 48 of the balloon 24towards a magnetized portion 60 of the guide-wire 50 to dispose theflexible, absorbent, porous portion 18 of the balloon 24 against theinternal mammalian tissue 64, which may comprise the pulmonary veinostial tissue, pulmonary vein tissue 76, or the endocardial surface, ofthe left atrium 74. Blood 77 may flow from the pulmonary vein 76 throughthe second lumen 34 of the balloon 24 into the left atrium 74. This mayminimize or eliminate temporary reduction of blood flow from thepulmonary vein 76 into the left atrium 74 during use of the balloon 24.An attachment member 81, such as a clip or other type of attachmentmember, may be used in the embodiment in which the ferromagnetic portion48 of the balloon 24 is attracted towards the magnetized portion 60 ofthe guide-wire 50. When the balloon 24 is located in the desiredlocation relative to the tissue being treated, the attachment member 81may be used to fixedly attach the guide-wire 50 to the sheath 68 to keepthe balloon 24 and the guide-wire 50 at a fixed distance apart from oneanother during treatment. This will result in the magnetic fieldexerting a constant electromagnetic force between the magnetized portion60 of the guide wire 50 and the ferromagnetic portion 48 of the balloon24 keeping the balloon 24 in the desired location to treat the tissuefor any desired period of time.

As illustrated in FIG. 5, a substance 12 may be infused, using aninfusion device 73, through the second catheter lumen 39, into the thirdlumen 36, and into the cavity 22 in order to inflate/expand the cavity22 of the balloon 24 with the substance 12. The substance 12 maycomprise any substance for altering physiologic properties of internalmammalian tissue 64, such as pulmonary vein ostial tissue, pulmonaryvein tissue 76, or endocardial surface tissue, of the left atrium 74, orother types of mammalian tissue. The substance 12 may comprise anyantiarrhythmic medication which is effective when applied topically, orany other drug that may have antiarrhythmic effects. The substance 12may comprise drugs in CLASS 1, CLASS 2, CLASS 3, CLASS 4, or any othersubstance, currently known or discovered in the future, that affectstissue for the treatment of any type of health-related issue. Thesubstance 12 may comprise any of the following: amiodarone, quinidine,disopyramide, lidocatine, procainamide, dofetilide, azimilide,flecainide, encainide, sotolol, propafenone, or other medications usedto treat atrial fibrillation such as beta blockers or calcium channelblockers. The substance 12 may comprise any neuro toxic or cardio toxicagent, currently known or discovered in the future, which achieves adesired therapeutic effect when applied directly to the endocardium atsufficient concentrations, and for sufficient duration. These substanceswill alter the electrochemical properties of the tissue being treatedwithout destroying or ablating the myocardial cells. The substance 12may comprise any liquid agent for ablating myocardial tissue such asdesiccated alcohol, or other substances that may induce chemicalinfarction or apoptosis of myocardial cells to ablate an arrhythmiaimpulse. The substance 12 may further comprise, or be mixed with, ananti-coagulant medication or any combination of medications necessaryfor safe and effective treatment.

As shown in FIG. 6, the substance 12, disposed in the cavity 22 betweenthe flexible, absorbent, porous portion 18 of the member 16 and thenon-porous portion 20 of the member 16, may then be infused, using theinfusion device 73, through the flexible, absorbent, porous portion 18to saturate the flexible, absorbent, porous portion 18 and contact theinternal mammalian tissue 64, which may comprise pulmonary vein ostialtissue, pulmonary vein tissue 76, or an endocardial surface of the leftatrium 74. The substance 12 may alter the physiologic properties of theinternal mammalian tissue 64 to treat arrhythmia. In one embodiment, thesubstance 12 may ablate internal mammalian tissue 64, such as pulmonaryvein ostial tissue, pulmonary vein tissue 76, or an endocardial surfaceof the left atrium 74, to treat arrhythmia. This may lead to substantialimprovement in arrhythmia and/or in arrhythmia being completely cured.Due to the blood 77 being allowed to flow from the pulmonary vein 76through the second lumen 34 of the balloon 24 into the left atrium 74,minimizing or eliminating the temporary reduction of blood flow from thepulmonary vein 76 into the left atrium 74 during use of the balloon 24,the substance 12 may be infused through the flexible, absorbent, porousportion 18 into contact with the internal mammalian tissue 64 for aprolonged period of time (such as a few minutes, an hour, a few hours,days, weeks, or other periods of time) at any necessary concentration toachieve the desired effect. During this time, the effect of thesubstance 12 on the mammalian tissue 64 may be monitored in order toachieve effective results prior to removing the substance 12 from beingin contact with the mammalian tissue 64. Moreover, during this time,varied substances 12 having differing effects may be sequentiallyapplied to tailor the treatment to the particular patient in order toachieve the desired results. In other embodiments, any number ofsubstances 12 may be infused through the flexible, absorbent, porousportion 18 into contact with the internal mammalian tissue 64 at anyconcentration or duration.

As shown in FIG. 7, after the mammalian tissue 64 around hole 75 of theleft atrium 74 has been fully treated, the infusion device 73 may beused to apply negative pressure suction in order to vacuum the substance12 out of the balloon 24 to put the balloon 24 back into an unexpandedstate. This may be done by using the infusion device 73 to vacuum thesubstance 12 out of the cavity 22, through the third lumen 36, and outof the second catheter lumen 39 in order to vacuum the substance 12 outof the cavity 22 of the balloon 24. During this process, the flexible,absorbent, porous portion 18 and the non-porous portion 20 of theballoon 24 may begin to compress and crinkle as the cavity 22 is emptiedof the substance 12, and the attachment clip 81 may be released. Theguide-wire 50 may be moved to move the stepped-up portion 52 of theguide-wire 50 through the tapered hole 29 in the nipple 28 until itabuts against the base surface 31 of the nipple 28.

As shown in FIG. 8, the guide-wire 50 may be moved to retract the nipple28 of the member 16 out of the hole 75 of the left atrium 74 due to thestepped-up portion 52 of the guide-wire 50 abutting against and forcingthe base surface 31 of the nipple 28 out of the hole 75. As shown inFIGS. 1 and 2, the stepped-up portion 52 of the guide-wire 50 has awider width 54 than the width 44 of the first lumen 44. The nipple 28 ofthe member 16 may subsequently be inserted at separate times into otherholes, comprising other pulmonary vein ostiums, of the left atrium 74.As described above with respect to hole 75, the substance 12 may beinfused, using the same process, into the other holes, in order to treatthe tissue around each of these holes. In such matter, the member 16 maybe used to treat all internal mammalian tissue 64, comprising pulmonaryvein ostial tissue, pulmonary vein tissue 76, or endocardial surfaces ofthe left atrium 74, which require treatment to improve or resolvearrhythmia. After all of the desired internal mammalian tissue 64 hasbeen treated, the stepped-up portion 52 of the guide-wire 50 may bemoved against the base surface 31 of the nipple 28 to force theflexible, absorbent, porous portion 18 to gradually collapse within thenon-porous portion 20 of the deflated balloon 24 from the configurationof FIG. 8, to the configuration of FIG. 9, into the configuration ofFIG. 10 in which it is disposed in a tulip configuration within thenon-porous portion 20 of the balloon 24. As shown in FIGS. 8-10, as thestepped-up portion 52 of the guide-wire 50 is moved, the deflatedballoon 24 is forced to gradually retract from the position of FIG. 8,to the position of FIG. 9, and into the position of FIG. 10 in which itis disposed completely retracted back in the stowed position within thesheath 68. The balloon 24 material is sufficiently soft and malleable toallow easy retraction back into the collapsed configuration within thesheath 68. During this process, one or more Nitinol runners 49,connected between the flexible, absorbent, porous portion 18 and thecatheter 26, may be used to assist in retracting the balloon 24 backinto the sheath 68. The retracted balloon 24, stowed in theunexpanded/deflated state within the sheath 68, may then be removed fromthe mammal along with the sheath 68. This may be accomplished byfollowing the first lumen 32 of the balloon 24 along the guide-wire 50in order to remove the balloon 24 and the sheath 68 from the pulmonaryvein 76.

One or more embodiments of the disclosure may allow for the chemicaltreatment of atrial fibrillation, or other non-atrial fibrillationinternal mammalian tissue issues, using a malleable, expansile,absorbent surface which consistently contacts the targeted endocardialand pulmonary vein tissue to deliver the chemical to the targeted celltissue, without leaving gaps, and without relying on the currenttechnique of delivering multiple ablative injury lines. This treatmentallows the chemical to be narrowly applied to only the targeted tissuethrough a much easier and less-costly method than current treatmentsusing standard interventional cardiology techniques which may beperformed by any operator trained in catheter based cardiac procedures,as well as electrophysiologists, allowing for the treatment of patientsworldwide, many of which currently lack access to treatment. Thistreatment may allow for the avoidance of serious side effects associatedwith current drug treatments as a result of eliminating the need forhigh dose systemic ingestion of drugs, thus avoiding side effects andtoxicities. Moreover, this treatment may reduce the risk of serious sideeffects associated with current catheter based ablation techniques dueto the use of the apparatus 10. The treatment may have the followingbenefits over current catheter based ablation techniques: beingless-traumatic to the myocardium; not requiring focal contact of acatheter tip to atrial tissue; not requiring delivery of radiofrequencybased thermal injury, or cold cryo based injury; not requiringelectrical mapping of the targeted tissue; may be applied directly toeach of the pulmonary vein Ostia and surrounding left atrial tissue; mayallow anti-arrhythmic medications or other substances to be directlyapplied to the targeted tissue to interfere with the cellular membraneelectrochemical properties which trigger the myocardial cellfibrillation; may allow any number of substances to be applied, togetheror sequentially, to the tissue for varied durations and at variedconcentrations; and may allow effective treatment of the atrialfibrillation without injuring the cell function itself resulting inaverting the potential for the complication of pulmonary vein stenosis,cardiac perforation, or injury related embolization.

It should be understood, of course, that the foregoing relates toexemplary embodiments of the disclosure and that modifications may bemade without departing from the spirit and scope of the disclosure asset forth in the following claims.

I claim:
 1. An apparatus for applying a substance to internal mammaliantissue comprising: a member having a flexible, absorbent, porous portionconnected to a non-porous portion to form an inflatable and deflate-ablecavity between the flexible, absorbent, porous portion and thenon-porous portion, wherein the flexible, absorbent, porous portion iscompliant to a shape of the internal mammalian tissue, wherein themember includes a lumen extending along a long axis of the member and atleast partially positioned in the cavity and configured to communicatethe substance to the cavity, and wherein the member includes a nipple atan end of the member; wherein the lumen is a first lumen, the memberalso including a second lumen and a third lumen, the second lumenextending from a lateral surface of the member through the end of themember and into the nipple, the third lumen extending along the longaxis of the member through the end of the member and into the nipple. 2.The apparatus of claim 1 further comprising a fourth lumen extendingfrom a lateral surface of the member through the end of the member andinto the nipple.
 3. The apparatus of claim 2 wherein the lateral surfaceof the member is at least partially comprised of the non-porous portion,and wherein the second and fourth lumens extend from the non-porousportion into the nipple.
 4. The apparatus of claim 3 wherein the secondand fourth lumens extend through the cavity.
 5. The apparatus of claim 2wherein the second and fourth lumens are crescent shaped.
 6. Theapparatus of claim 1 wherein the lateral surface of the member is atleast partially comprised of the non-porous portion, and wherein thesecond lumen extends from the non-porous portion into the nipple.
 7. Theapparatus of claim 6 wherein the second lumen extends through thecavity.
 8. The apparatus of claim 1 wherein the lumen is aligned withand attached to a catheter.
 9. The apparatus of claim 1 wherein thesecond and third lumens are open-ended.
 10. The apparatus of claim 1further comprising a guide-wire, wherein the guide-wire has a stepped-upportion which has a width which is greater than widths of other portionsof the guide-wire, and the width of the stepped-up portion is alsogreater than a width of the third lumen.
 11. The apparatus of claim 1wherein the second lumen is crescent shaped.
 12. An apparatus forapplying a substance to internal mammalian tissue comprising: a memberhaving a flexible, absorbent, porous portion connected to a non-porousportion to form an inflatable and deflate-able cavity between theflexible, absorbent, porous portion and the non-porous portion, whereinthe flexible, absorbent, porous portion is compliant to a shape of theinternal mammalian tissue, wherein the member includes a lumen at leastpartially positioned in the cavity and configured to communicate thesubstance to the cavity, and wherein the member includes a nipple and aferromagnetic portion in the nipple; and a guide-wire, wherein theguide-wire has a magnetic member for being magnetized, wherein themagnetic member has a stepped-up portion wider than another portion ofthe guide wire, and wherein ferromagnetic portion of the member is atleast one of attracted to or repulsed by the magnetic member of theguide wire.
 13. The apparatus of claim 12 wherein the lumen extendsthrough a long axis of the member.
 14. The apparatus of claim 13 whereinthe lumen is a first lumen, the apparatus further comprising a secondlumen, wherein the width of the stepped-up portion of the guide wire isgreater than a width of the second lumen.
 15. The apparatus of claim 12wherein the magnetic member is an electromagnet.
 16. The apparatus ofclaim 15 wherein the magnetic member is adjustable to adjust a strengthof the at least one of the attraction or repulsion of the magneticmember.
 17. The apparatus of claim 12 wherein the lumen is aligned withand attached to a catheter.
 18. The apparatus of claim 12 wherein thelumen is a first lumen, the member also including a second lumenextending from a lateral surface of the member through an end of themember.
 19. The apparatus of claim 12 wherein the lumen is a firstlumen, the member further comprises second and third lumens, the secondand third lumens are open-ended.
 20. The apparatus of claim 12 whereinthe nipple extends from the flexible, absorbent, porous portion, whereinthe member includes a second lumen that extends through the nipple. 21.The apparatus of claim 12 wherein the nipple includes a base surface andthe ferromagnetic portion is in the base surface of the nipple.